All Commentary
Thursday, February 1, 1996

Bioethics Opportunities, Risks, and Ethics: The Privatization of Cancer Research

The Government-Academic Monopoly Denies Treatment to Cancer Patients

Bioethics burst onto the scene last decade. Its mission: to analyze and judge the moral aspects of clinical and research medicine. Dr. Robert K. Oldham argues that ethical conduct “is simply a matter of doing that which is right.” In Bioethics, he sets out to challenge the legitimacy of his most vocal critics: medicine’s “mainstream” bioethicists.

Oldham’s ongoing “war” with mainstream bioethicists stems from his challenge to the government-academia monopoly controlling therapeutic research that has evolved since World War II. The current generation of researchers and academics—ignorant of the entrepreneurial paradigm that guided research in the United States prior to World War II—find Dr. Oldham’s statements and actions outrageous and troubling. And they should, for Oldham seeks to overthrow them.

Dr. Oldham is a highly respected cancer therapist specializing in the exciting new field of biotherapy. Biotherapy research is presently studying and developing ways to launch a coordinated attack on the tumor using the cancer patient’s own immune system. Biotherapy rests on the premise that although each cancer has characteristics held in common with all other tumors of the same cell type, it also has certain individualizing characteristics distinguishing it from all other cancers of the same type.

With this insight, biotherapy has developed immune-enhancing therapies that are specific to an individual tumor and are less toxic and more effective than generalized immunologic therapies. These agents, either singularly or in combination “cocktails” are tailored for unique application to the specific patient. Much of this research is done by private medical technology companies.

Dr. Oldham founded the Oncology Program at Vanderbilt University College of Medicine. Later, he headed the Biotherapy Research Division at the National Cancer Institute, where he discovered an inherent flaw in the current drug development process. The current process involves research largely funded by the taxpayer or the pharmaceutical industry. Strict protocols established by the Food and Drug Administration must be followed, under penalty of law. This is not costless. The average length of time it takes to bring a new drug to market is ten years. The average cost runs in the hundreds of millions of dollars. Bad as this is, it is worse for cancer patients.

Oldham focuses on a particular problem that arises when a breakthrough occurs in therapeutic research. The anticipated tumor cure will not be made available, even on an experimental basis, to that patient until a few more years of FDA-required trials are completed. Such patients, the large majority of whom will be dead before the FDA finishes its trials, are denied access to a therapy despite having subsidized its research, and even despite their potential willingness to pay more to have this therapy, regardless of its experimental status. This is unethical. Research allegedly driven by the needs of patients is instead driven by the abstract needs of the experiment. Patients dying of cancer find the delay unacceptable, and the bureaucratic concern for their welfare ludicrous. Their time is running out.

Dr. Oldham left the National Cancer Institute in 1984 and founded Biotherapeutics, Inc., a for-profit, patient- funded cancer research company. Patients contracted for specific biotherapeutic regimens produced in this private lab and administered experimentally in Oldham’s Biological Therapy Institute. The Institute reports the results of its research, both the promising and the unsuccessful. Since most biotherapies are produced on-site there is no interstate transport, and these agents are therefore exempt from FDA regulation.

The idea of patients engaging in voluntary contractual treatment was too much for the “medical-academic- governmental complex.” Dr. Oldham came under forceful attack from bioethicists who charged that it was unscrupulous to ask patients to pay for their research. Dr. Oldham countered that the current scenario is worse—forcing them to pay for research they are then denied.

Bioethicists also asserted the appearance of a conflict of interest when the research is performed by a for- profit institution. Dr. Oldham cited work by Nobel laureate economist James Buchanan founder of the public choice school of economics that applies economic theory to analyze political actors—and argued that non- profit and governmental institutions are at a greater risk for conflicts of interest, conflicts more easily hidden from the public given the lack of competitive forces.

Unfortunately, bad publicity resulting from his critics and bad business management decisions led to the demise of Biotherapeutics, Inc., in 1989. The Biological Therapy Institute remains, still directed by Dr. Oldham, but the prospects for speeding up available cancer therapy options for patients have been dealt a blow.

In Bioethics, Dr. Oldham exposes the reader to the fascinating prospects for medical research privatization. He makes the case that the current government-academic monopoly has come to regard the patient’s interest as secondary to the interests of “science.”

The reader is also introduced to the new field of bioethics, and exposed to debates on its legitimacy, both pro and con. Ethical arguments for and against patient-funded and for-profit research are presented at length.

Bioethics also contains an excellent discussion on the doctor-patient relationship. Dr. Oldham advocates a consensual relationship, in which the patient contracts with the doctor for a service and actively participates in all significant decisions with respect to his treatment. Oldham here creates (unknowingly) a medical analogy to the psychiatric relationship advocated by iconoclastic libertarian psychiatrist Thomas Szasz, M.D., in The Ethics of Psychoanalysis and other writings. Szasz called his approach “autonomous psychotherapy.” We could call Oldham’s approach “autonomous cancer therapy.”

Bioethics is a series of reprinted articles and essays by Dr. Oldham and others, arranged to lead the reader through the story of Dr. Oldham’s project and various implications of his thesis. The drawback of this format is that there is a tendency towards redundancy, as articles intended for different audiences repeat points already made. Author commentary tying together the is-sues and arguments made by these essays would have been appreciated, but is not included.

Despite these shortcomings, Bioethics is an extremely important work that deserves wide attention. It deals with issues rarely raised, but issues that are literally matters of life and death.

Dr. Singer practices medicine in Phoenix, Arizona.